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Menopausal symptoms and black cohosh -

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Norman Swan: The conference I was at in New Zealand for that 12 hours was the annual international meeting of the Cochrane Collaboration, which we've often mentioned on The Health Report. Cochrane is a global collaboration of researchers who bring together the available evidence on an issue, review it for quality and reliability, and try to conclude what the best advice might be for treatment or prevention.

You might have noticed some news about the risks or not of menopausal hormone replacement therapy during the last week. That's one of the main interests of Cochrane reviewer Helen Roberts whose day job is as associate professor of women's health in the department of obstetrics and gynaecology at the University of Auckland.

Helen Roberts: Well, we've been looking at various things with the data. We've been looking know, if you use it for a long term, what is the effect on having heart disease or stroke or breast cancer or clots in the legs, that sort of stuff. And we've also been looking at the effect on the endometrium, the lining of the womb. But I think particularly when you start to look at the most recent research coming out of WHI…

Norman Swan: This is the Women's Health Initiative which...this large randomised trial.

Helen Roberts: That's right. So the women's health initiative, the first publications were 2002 and they were the publications of women using oestrogen and progesterone, combined hormone therapy versus placebo, and looking at outcomes such as stroke and breast cancer, et cetera. Those women in that original study were aged 50 to 79. So the mean age was 63. So they are a lot older than women we actually see in clinics coming in at 50 saying, 'I've got flashes, I want to use something, can you tell me the pluses and the minuses.'

What happens now is since that original publication in 2002, they have brought up what we call subgroup analysis. So they've looked at smaller groups of women, particular groups of women, and the interesting one is women aged 50 to 59, and then given us figures for that group of women for the risk-benefit analysis. That makes it an awful lot better to actually talk to somebody, 'You're 55, this is your risk that came out from the study.' So I think that has been useful for us.

Norman Swan: Rather than applying a risk which is for an older woman who, just because of age, would be at greater risk of breast cancer, for example.

Helen Roberts: That's exactly right, because of course the older you get, the higher background risk of these diseases are. And I think for a healthy woman around the age of menopause, 50 to 51, who has got symptoms that are really affecting her quality of life, like night sweats particularly I think is the one that really affects women because they can't sleep, then the risks of using hormone therapy are going to be very acceptable and very low.

Norman Swan: So what does your analysis show or the subgroup analysis for that group of women show in terms of their risk?

Helen Roberts: So if you actually look at, for example, women who are using combined therapy, those are women who have got a uterus, so you use oestrogen and you have to use the progesterone as well because that protects the lining of your womb, you have to use the two hormones...

Norman Swan: Which is to protect against the risk of uterine cancer.

Helen Roberts: It is indeed. And if you look at those women, for example, the risk of breast cancer is an extra five...this is finding breast cancer, this is not death from breast an extra five women per 10,000 women a year will have a breast cancer found because she has been using the combined hormone therapy.

If you look at the World Health Organisation classification of risks, they say any event 1 to 10 per 10,000 per year is a rare event, so most of the classifications in that age group are actually in the rare event area. So for most women that's a very reassuring thing to know.

Norman Swan: And is that lifetime risk or risk in that decade of your life?

Helen Roberts: This is per year, 10,000 women per year.

Norman Swan: Per year of use?

Helen Roberts: Per year of use, exactly. And that brings me onto the next point I was going to talk about, is that when you stop your hormone therapy, 2.5 years after you've stopped the majority of risks go back to baseline again.

Norman Swan: So you're not harbouring a problem that is going to emerge in your 70s.

Helen Roberts: The only small risk that continued was there was still a small increased risk of breast cancer after 2.5 years, and a very small risk of quite a rare sort of lung cancer, which means that the absolute risk was tiny. Your stroke risk had gone, your clot risk had gone, and the benefits for bone had also gone. So the pluses and minuses...mainly all of them had gone back to baseline.

Norman Swan: So the bottom line here is if you're a healthy woman in your 50s, taking hormone replacement therapy for a year or two is probably neither here nor there.

Helen Roberts: It's probably in a risk situation that most women would say, 'I absolutely accept that risk. I think it's a small risk and I would really like the benefit.' And I think the thing that women sometimes don't understand or they often ask about is, 'Helen, am I just going to be covering over my symptoms, and then when I stop my symptoms will just come back?' And we really believe what you're doing is you're taking whatever you're taking for the length of duration of your symptoms. What I mean by that is for most women their hot flushes and night sweats are self-limiting. Meaning, they have disappeared one to two maybe five years from menopause, the majority of women, thank heavens, their symptoms go. And that's really important for women to know, that whatever they are using they may only need to use for a year or two.

Norman Swan: And does the way they stop count? In other words, stopping cold turkey versus cutting it down by half, by half, by half?

Helen Roberts: Very good. And we actually do have a randomised trial about that and it shows no difference.

Norman Swan: So you can stop cold turkey?

Helen Roberts: So you can stop cold turkey. But I'll tell you something, if you give people a choice, they say, 'Helen, I think I'll just come off it slowly and see.'

Norman Swan: I recently did an interview with Susan Reed from WHI in Seattle who is using intermittent progesterone three or four times a year for a week or two. Is there any evidence to back that up?

Helen Roberts: I think the evidence would not probably back that up, I think the evidence we had...when we did the review that looked at the lining of the womb and it looked at various doses of oestrogen and particularly the doses of progesterone you needed for protection, it very much showed that intermittent progesterones didn't work. Now, she may be using a different type or a different dose, but so far the data we have would say no. So if you've got a uterus and if you're a young menopausal woman you need to use your progesterone for 14 days. And if you are an older menopausal woman, you need to use it every day. So intermittent, so far no good data to show it would protect enough.

Norman Swan: And just finally, you reviewed…these things in Cochrane called systematic reviews where you bring together the evidence on a given subject from randomised trials, and two researchers in Australia in Adelaide have put out a review of black cohosh, which you were the reviewer of the review. And given that they are not here to talk to me, what were their findings on black cohosh? This is a fairly popular alternative medication.

Helen Roberts: Yes, and black cohosh has been around for a very, very long time.

Norman Swan: What is it?

Helen Roberts: It's a plant and it grows in Canada and Eastern USA, and has actually been used by North American Indian women for period problems. So it has been around for ages and because you can buy it across the counter, a lot of women have used it for their hot flushes, because women like to be able to do things for themselves, they don't always want to have to go to a health professional.

And basically what this review did, it looked at 16 studies that compare the black cohosh with either placebo (a tablet that looked like the black cohosh), or with hormone therapy. And basically for the hot flushes and night sweats, it found that hot flushes weren't any better than placebo. Why that is important is if you came to me with hot flushes and I gave you a big bag of Smarties to take home and you came back in six months and said, 'Helen, these Smarties are great, can I have some more?' I don't know if the Smarties helped you or if your flushes stopped because you were a short-term flusher, that's why you need the placebo. You need to know that what you are using is better than actually not using anything at all.

So unfortunately this review came out and actually clearly showed from these 16 studies of over 2,000 women, that black cohosh wasn't helping hot flushes and night sweats any better than placebo does. The quality of the studies weren't great, and the review…the authors very much point out that we'd like better studies, but at this point in time women are probably wasting their money if they're using black cohosh for their flushes.

Norman Swan: And harm?

Helen Roberts: No, that was the good thing, there wasn't really a lot of evidence of harm. There have been other reviews and there has been a bit of a query about liver toxicity. But there really hasn't been any causation found from the black cohosh. So,a fairly safe thing but perhaps not useful. We were at a Cochrane colloquium meeting here in Auckland and we've got this great thing called, and it would be really good for women. Women can Google that ( and they can actually then look for black cohosh, they can find any review they want, anything they're interested in, and get all the evidence so they can actually get the information for themselves. I'd urge everybody to have a wee look at that.

Norman Swan: And it's in plain language.

Helen Roberts: Hopefully in plain language, yes.

Norman Swan: Helen Roberts, thank you.

Helen Roberts: You're welcome.

Norman Swan: Associate professor Helen Roberts who is in the department of obstetrics and gynaecology at the University of Auckland.